Vilazodone for Corticosteroid-Induced Memory Impairment

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Forest Laboratories
Information provided by (Responsible Party):
Sherwood Brown, University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier:
NCT01828515
First received: November 7, 2012
Last updated: April 15, 2014
Last verified: April 2014
  Purpose

The purpose of this study is to examine whether vilazodone attenuates the memory and mood effects of corticosteroids on the human hippocampus in 18 healthy controls.


Condition Intervention Phase
Memory Impairment
Drug: Vilazodone
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Vilazodone for Corticosteroid-Induced Memory Impairment

Resource links provided by NLM:


Further study details as provided by University of Texas Southwestern Medical Center:

Primary Outcome Measures:
  • The primary outcome measure will be change in declarative memory as assessed by the RAVLT (Rey Auditory Verbal Learning Test) from baseline. [ Time Frame: 19 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • A secondary outcome will be change in mood as measured by the ISS (Internal State Scale) from baseline. [ Time Frame: 19 days ] [ Designated as safety issue: No ]

Estimated Enrollment: 18
Study Start Date: December 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Vilazodone
vilazodone titrated to 10 mg x 7 days, 20 mg x 7 days and 40 mg x 5 days (19 days)
Drug: Vilazodone
Participants will be randomized to either vilazodone or placebo titrated as follows: 10 mg x 7 days, 20 mg x 7 days and 40 mg x 5 days.
Other Name: Viibryd
Placebo Comparator: Placebo
placebo, daily for 19 days
Drug: Placebo

Detailed Description:

In animals and humans, stress and corticosteroid excess are associated with changes in hippocampal structure and functioning. These findings have important implications to the millions of patients taking prescription corticosteroids and to patients with major depressive disorder or bipolar disorder who have elevated cortisol levels and memory impairment. The investigators believe that vilazodone may be a medication that can block the effects of hydrocortisone on the human hippocampus. The investigators propose to examine whether vilazodone attenuates the effects of corticosteroids in a randomized, double-blind, placebo-controlled pilot study using a within-subject crossover design.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy men and women age 18-50 years
  • Education of ≥ 12 years and baseline RAVLT total words recalled score ≥ 35 (normal baseline memory)
  • BMI between 18.5-30 (not underweight or obese)

Exclusion Criteria:

  • History of major psychiatric illness defined as major depressive disorder, bipolar disorder, posttraumatic stress disorder, panic disorder, schizoaffective disorder, schizophrenia, eating disorders, or drug/alcohol abuse/dependence or current tobacco use
  • History of neurological disorders including seizures, brain surgery, multiple sclerosis, Parkinson's disease
  • Taking CNS-acting medications within 30 days of study
  • History of allergic reaction or medical contraindication to vilazodone or hydrocortisone
  • Significant medical conditions (e.g., myocardial infarction, cancer, diabetes)
  • Vulnerable population including pregnant or nursing women, the incarcerated, and severe cognitive disorders
  • Baseline HRSD (Hamilton Rating Scale for Depression) > 7 or current suicidal ideation or history of suicide attempt
  • History of systemic Corticosteroid (CS) use or recent (past 6 months) inhaled CS use
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01828515

Locations
United States, Texas
UT Southwestern Medical Center
Dallas, Texas, United States, 75390
Sponsors and Collaborators
University of Texas Southwestern Medical Center
Forest Laboratories
Investigators
Principal Investigator: E. Sherwood Brown, M.D., Ph.D. UT Southwestern Medical Center
  More Information

No publications provided

Responsible Party: Sherwood Brown, Professor, University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT01828515     History of Changes
Other Study ID Numbers: 082012-082
Study First Received: November 7, 2012
Last Updated: April 15, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Memory Disorders
Nervous System Diseases
Neurobehavioral Manifestations
Neurologic Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on October 29, 2014